Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has recently completed subject randomization of the Phase III clinical trial (Kinect 3 Study) of its proprietary Vesicular Mono-Amine Transporter 2 (VMAT2) compound NBI-98854 in tardive dyskinesia patients.
The design of the Kinect 3 Study is a randomized, parallel-group, double-blind, placebo-controlled trial of approximately 240 subjects with moderate to severe tardive dyskinesia and an underlying diagnosis of mood disorder, schizophrenia or schizoaffective disorder. The initial six weeks of treatment consists of an efficacy and safety assessment of 80mg and 40mg once-daily NBI-98854 against placebo. This will be followed by an additional 42 weeks of long-term safety assessment where all subjects are randomized in a blinded fashion to either 80mg or 40mg once-daily NBI-98854. Topline efficacy data from the initial six week assessment is expected in the fourth quarter of 2015.
"Completing enrollment of the Kinect 3 study is another milestone in the development of NBI-98854 and we look forward to sharing the top-line results next quarter," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences.
Kinect 3 Study Design
The Kinect 3 study is a randomized, parallel-group, double-blind, placebo-controlled, Phase III clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder). The primary endpoint in the Kinect 3 study is the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks. Subsequent to the completion of the six week placebo-controlled dosing, all subjects will continue on once daily 40mg or once daily 80mg of NBI-98854 through Week 48.
The Kinect 3 study, along with the previous efficacy studies of NBI-98854, is designed to complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. In addition to this tardive dyskinesia study, a separate one-year open-label safety study of NBI-98854, Kinect 4, has also been initiated to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.
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